Effect of natalizumab treatment on the rate of No Evidence of Disease Activity in young adults with multiple sclerosis in relation to pubertal stage

The consequences of interruption of natalizumab treatment are incompletely known. The objective was to assess the confirmed annualized relapse rates for patients preceding initiation, during and following suspension of natalizumab therapy. A chart review was conducted and data were analyzed using the Generalized Estimating Equations. During natalizumab therapy the confirmed annualized relapse rate was 0.08, compared to 0.52 ( p = 0.0003) during the prior 12 months and to 0.35 ( p = 0.0032) during the following 3 to 24 months. Similar results were found when confirmed and unconfirmed were analyzed. To conclude, following cessation of natalizumab therapy disease activity rapidly returned to pre-natalizumab levels.

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Real-world effectiveness of natalizumab treatment in patients with relapsing multiple sclerosis in Argentina and Chile

Arquivos de Neuro-Psiquiatria ◽

10.1590/0004-282x-anp-2020-0303 ◽

2021 ◽

Vol 79 (5) ◽

pp. 407-414

Author(s):

Maria Celica Ysrraelit ◽

Alejandro Caride ◽

Vladimiro Sinay ◽

Mario Rivera Kindel ◽

Mario Javier Halfon ◽

...

Keyword(s):

Multiple Sclerosis ◽

Clinical Practice ◽

Disease Activity ◽

Real World ◽

Disability Status ◽

Natalizumab Treatment ◽

Magnetic Resonance Imaging Mri ◽

One Year ◽

Practice Methods ◽

Relapsing Multiple Sclerosis

ABSTRACT Background: The real-world effectiveness of natalizumab in people with relapsing multiple sclerosis (PwRMS) in Argentina and Chile has not been reported. Objective: To evaluate the effectiveness of natalizumab treatment in PwRMS in Argentina and Chile, in clinical practice. Methods: We conducted a multicenter retrospective and observational study. We reviewed the medical records of PwRMS who had been treated with natalizumab for at least one year, without any interruption in MS treatment that lasted more than 12 weeks. We analyzed changes in annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score and magnetic resonance imaging (MRI). Results: We enrolled 117 PwRMS treated with natalizumab. Natalizumab treatment was associated with a significant reduction in ARR from baseline after one year and two years of treatment (from 1.97 to 0.06 and 0.09 respectively; p<0.01 at each time point). From baseline, EDSS scores were reduced by 0.71 and 0.73 points at one and two years, respectively (p<0.01). No worsening of disability was observed in 82.9 and 67.5% of PwRMS at one and two years, respectively. The improvement in disability was 44.4% at one year and 39.3% at two years. During natalizumab treatment, the number of relapse-related hospitalizations was significantly reduced (p<0.01). MRI lesions (new/enlarging T2 or gadolinium-enhancing) were significantly reduced, compared with baseline. No evidence of disease activity was observed in 65% at two years of natalizumab treatment. Conclusions: Natalizumab significantly reduced disease activity in PwRMS in Argentina and Chile, in clinical practice. Natalizumab also decreased the number of hospitalizations compared with pre-natalizumab treatment.

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Disease activity return during natalizumab treatment interruption in patients with multiple sclerosis

Neurology ◽

10.1212/wnl.0b013e31823c1200 ◽

2011 ◽

Vol 77 (21) ◽

pp. 1930-1931 ◽

Cited By ~ 3

Author(s):

K. W. Rammohan ◽

M. R. Ortega ◽

S. R. Delgado ◽

L. Tornes ◽

P. W. O'Connor

Keyword(s):

Multiple Sclerosis ◽

Disease Activity ◽

Treatment Interruption ◽

Natalizumab Treatment

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Relapse Rate and MRI Activity in Young Adult Patients With Multiple Sclerosis: A Post Hoc Analysis of Phase 3 Fingolimod Trials

Multiple Sclerosis Journal - Experimental Translational and Clinical ◽

10.1177/2055217318778610 ◽

2018 ◽

Vol 4 (2) ◽

pp. 205521731877861 ◽

Cited By ~ 5

Author(s):

Jutta Gärtner ◽

Tanuja Chitnis ◽

Angelo Ghezzi ◽

Daniela Pohl ◽

Wolfgang Brück ◽

...

Keyword(s):

Multiple Sclerosis ◽

Young Adults ◽

Disease Activity ◽

Relapse Rate ◽

Negative Binomial ◽

Age Groups ◽

Young Patients ◽

Negative Binomial Regression ◽

Phase 3 ◽

Double Blind

Background Disease activity differs in young patients with multiple sclerosis (MS) compared with the overall adult MS population. Objective The objective of this paper is to evaluate the effect of fingolimod 0.5 mg on disease activity in young adults with MS from three randomized, double-blind Phase 3 trials. Methods Annualized relapse rate (ARR), number of new/newly enlarging T2 lesions (neT2), and no evidence of disease activity (NEDA-3) were estimated in the intent-to-treat population at age 20 (youngest) and 30 (young) and compared to the overall population. Models used included a negative binomial regression (ARR/neT2) and a logistic regression (NEDA), with age at baseline as a continuous covariate. Results ARRs were higher in younger patients (all p < 0.05), and significantly reduced with fingolimod versus placebo or interferon beta-1a (IFN β-1a), with the percentage reduction inversely proportional to age. Fingolimod was significantly associated with a lower number of neT2 lesions versus placebo/IFN in all age groups except versus IFN in the youngest patients. Regardless of age, fingolimod-treated patients were more likely to achieve NEDA-3 versus placebo/IFN β-1a, with strongest benefits in the youngest patients (all p < 0.05). Conclusions Young adults show higher levels of MS disease activity, and may particularly benefit from fingolimod treatment compared with the overall study population.

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Observations during an elective interruption of natalizumab treatment: a post-marketing study

Multiple Sclerosis Journal ◽

10.1177/1352458510392098 ◽

2010 ◽

Vol 17 (3) ◽

pp. 372-375 ◽

Cited By ~ 23

Author(s):

Giovanna Borriello ◽

Luca Prosperini ◽

Fabiana Marinelli ◽

Federica Fubelli ◽

Carlo Pozzilli

Keyword(s):

Multiple Sclerosis ◽

Disease Activity ◽

Treatment Interruption ◽

Duration Of Treatment ◽

Continuous Therapy ◽

Optimal Duration ◽

Natalizumab Treatment ◽

Post Marketing ◽

The Difference

In this prospective post-marketing study, 21 patients with multiple sclerosis treated with natalizumab for 24 consecutive months elected a trial of treatment interruption (90–180 days). During a mean duration of treatment interruption of 111.5 days 4 patients (19.0%) experienced a relapse and 9 out of 19 (47.4%) had MRI activity. Number of contrast-enhancing lesions at baseline was lower than during treatment interruption, but the difference was not significant. These findings suggest that disease activity may return after the last infusion of natalizumab. Patients should have regular MRI assessment during treatment interruption to rapidly identify any return of disease activity. The aim of this study was to determine the optimal duration for temporary interruption of natalizumab therapy in patients who have received continuous therapy with natalizumab for 24 months.

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